Access to essential medicines is a human right and a cornerstone of an effective primary health care system. Access to free essential medicines determines whether people live or die, suffer pain and discomfort, or have their ailments cured, recover from illness or endure life-long disease.

The World Health Organization (WHO) defines essential medicines as “those that satisfy the priority health care needs of the population … Essential medicines are intended to be available within the context of functioning health systems at all times, in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford.” At the World Health Assembly in 1977, our governments made a commitment to ensure these essential medicines are available in public health facilities.”

Yet today, over 30 years later, at any given moment, public health facilities in Africa have in stock only about half of a core set of essential medicines. These are medicines used to treat common diseases such as malaria, pneumonia, diarrhoea, HIV, TB, diabetes and hypertension – all of which are among the highest causes of death in Africa.

Stock-outs are worst in rural areas and poor people are the most affected. Stock-outs force people to buy medicines at much higher prices from the private sector. More often, though, patients simply go without the medicine they so badly need – often with life-and-death consequences.

The “Stop the Stock-outs” campaign is calling on governments and health departments to end stock-outs now by:

• Giving financial and operational autonomy to the national medicines procurement and supply agency
• Allowing representation of civil society on the board of the national medicines procurement and supply agency
• Ending corruption in the medicine supply chain to stop theft and diversion of essential medicines.
• Providing a dedicated budget line for essential medicines
• Living up to commitments to spend 15% of national budgets on health care.
• Providing free essential medicines at all public health institutions.

The failure to properly stock public health clinics and pharmacies with essential medicines stems in part from economic constraints and bureaucratic obstacles. But above all, it is a failure of political will. If governments commit to having medicines on pharmacy shelves, they can do it.

We call on African governments to honour this commitment to finance essential medicines. We also call upon international allies and civil society actors to assist them. It is time to “Stop the Stock-outs, ensure Access to Essential Medicines for All!”

Download the Campaign Statement here [pdf 90kb]

Essential medicines were originally defined by the World Health Organization (WHO) as those which:

satisfy the needs of the majority of the population and therefore should be available at all times, in adequate amounts, in appropriate dosage forms and at a price the individual and community can afford.

Development of the concept

The idea of defining essential medicines – and establishing a list of them – was developed from a report made to the 1975 World Health Assembly. These efforts were aimed to increase the range and availability of medicines for populations with poor access.

The Expert Committee on the Use of Essential Medicines was established to assist member states to select and procure essential medicines. In 1977, the first report of the Expert Committee included (a) criteria for determining if a medicine fit the definition of an essential medicines and (b) the first model essential medicines list (EML) as two examples of how the concept of essential medicines could be implemented.

Since then WHO has updated the model EML every two years. In 2007, thirty years after introduction of the essential medicines concept, a model EML for children was also introduced.

Adapting the concept at national level

There should be clear links between the national EML, standard treatment guidelines, national expenditure on essential medicines, and procurement practices within the country.

The model EML is expected to be adapted at national level based on the local public health context of the country. Most countries have published a national EML. Most lists have been updated in the past five years; this exercise is crucial to reflect new therapeutic options and changing therapeutic needs.

Selection of medicines for the national EML

Within a country, the selection of essential medicines is usually a two-step process. The first involves regulatory approval, which is based on a review of efficacy, safety, and quality of medicines (without comparison between medicines). From these registered products, essential medicines within a therapeutic class are then selected on the basis of comparative efficacy, safety, and cost. To best ensure the widest acceptance of the list, the selection process for essential medicines needs the involvement of a number of stakeholders, including prescribers, dispensers, academics, health facilities, civil society, professional organizations, and others.

Before 2002, relatively expensive medicines were basically not found on the WHO model EML. This was successfully challenged by public health advocates and treatment activists. With the issue abolished, traditionally more expensive medicines (such as antiretrovirals) were quickly included on the WHO model EML and the official definition of essential medicines was updated to:

Essential medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost effectiveness. Essential medicines are intended to be available within the context of functioning health systems at all times, in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford. The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations; exactly which medicines are regarded as essential remains a national responsibility.

It is also important to stress that essential medicines are not second rate medicines for poor people, but that they represent the most cost effective treatments for a given condition

Weaknesses in the concept

The essential medicines concept and the model WHO EML have often been credited for establishing priorities for developing countries on selection of, and expenditure on, medicines to meet the needs of their populations. However, there is a concern that the process has eliminated some key medicines which, although they might not be needed for the majority of the population, may be crucial for the treatment of certain diseases (such as cancer) and specific age groups (such as the elderly).

Although considerable progress has been made in the 30 years since the WHO introduced the essential medicines concept, the benefits have been inequitable. Only two-thirds of the world’s population has access to the medicines they need, leaving one-third — about 2 billion people — without access. And in the poorest parts of Africa and Asia, more than half of the population lacks access.

A renewed commitment to the essential medicines concept is urgently needed in order to realize the spirit and intention of the deliberations of 1977.

References
1.World Health Organization. The selection and use of essential medicines. Report of the WHO Expert Committee, 2002 (including the 12th Model List of Essential Medicines). Technical Report Series No 914. Geneva: WHO,
2.Hans V Hogerzeil The concept of essential medicines: lessons for rich countries
3.Laing R, Waning B, Gray A, Ford N, ‘t Hoen E. 25 years of the WHO essential medicines lists: progress and challenges. Lancet 2003 May 17;361(9370):1723-9
4.Stolk P,Willemen MJC, Leufkens HGM. “Rare essentials” : drugs for rare diseases as. Essential Medicines. Lancet 2003;361:1723-9. 4.
5.J Robertson1 and SR Hill2 The Essential Medicines List for a Global Patient population
6.Backgrounder and Facts for launch of the United Nations report Delivering on the Global Partnerships for Achieving the Millennium Development Goals: WHO
7.World medicines situation

When a pharmacy (in a medical store or health facility) temporarily has no medicine on the shelf, it is known as a “stock-out”. It may affect one medicine or many medicines, or in the worst case, all medicines. A stock-out can be documented at one point-in-time or over a period of days, weeks or months. When there is good stock management systems in place, the stock-out duration will be minimal or, ideally, never.

The consequences of stock-outs for patients are grave:

• They have to travel to other health facilities or private sector which may be far away and often many times more expensive… or
• They may go without the medicines they need.
• They may get an alternative, appropriate or not, medicine.
• They lose confidence in the health facility to meet their needs.

The supply chain in developing countries:
Getting medicines to patients

• The government makes a “forecast” of how many medicines will be needed to manage and treat the population, based on the major public health challenges in the country.
• Orders and tenders are generated;
• Medicines are purchased and stored centrally;
• Medicines are distributed to regional stores and local health facilities;

In a push system, health facilities receive “kits” containing a set amount of medicines. The central and regional stores prepare and send these kits on a regular schedule.
In a pull system, the health facility decides the quantity of medicines needed and then they place orders for the medicines at the district, regional or central store.

• Medicines are dispensed to patients in health facility pharmacies.

Inefficiencies at any stage of the supply chain cause stock-outs.

• Inadequate funds for procurement of medicines
• Inaccurate and non-participatory forecasting
• Inadequate buffer stock of essential medicines at all levels of the supply chain
• Inefficient distribution systems at national and regional levels.
• Inadequate record-keeping

Is there information on stock-outs in my country?

WHO conducts surveys of countries’ pharmaceutical sectors to measure various aspects of the sector’s functioning, including the stock-out duration of medicines. This is done through retrospective analyses of stock-cards from the pharmacy records.

The graph shows the number of days a list of key essential medicines were out-of-stock in middle-level public health facilities in a year. The stock-out duration ranges from 25 to 89 days.

WHO and HAI monitor the availability (and price) of medicines in many African countries. This provides information on which medicines are, and which are not, on the shelves on the day of the survey. This gives useful information about the immediate availability situations, although it does not provide information about the duration which the medicine is off the shelves.

Taking action to eliminate stock-outs

• District health management teams should be participatory to encourage transparency and accountability in the supply chain
• Monitoring of availability of medicines at the health facilities
• Advocacy for 100% availability of essential medicines
• Advocacy for increased funding for essential medicines

References:
1.WHO and HAI (2008). Measuring medicine prices, availability, affordability and price components http://haiweb.org/medicineprices/
2.Community Case Management (CCM) Essentials: A Guide for Program Managers http://www.coregroup.org/ccm/ccm_field.html
3.Using indicators to measure country pharmaceutical situations. Fact book on WHO level I and level II monitoring indicators; available from http://www.who.int/medicinedocs/index/assoc/s14101e/s14101e.pdf
4.WHO (2000). Promoting Rational Use of Medicines: Core components
5.WHO and MOH (2002). Baseline Survey of the Pharmaceutical sector in Tanzania
6.WHO, HAI, MOH (2002). Uganda Pharmaceutical sector Baseline Survey
7.WHO and MOH (2003). Assessment of the pharmaceutical sector in Ethiopia
8.WHO, HAI, MOH (2003). Assessment of the pharmaceutical sector in Ghana
9.WHO, HAI, MOH (2002). Assessment of the pharmaceutical situation in Kenya: a baseline survey
10.Gray, A (1998). Using stock cards to improve drug management http://www.hst.org.za/uploads/files/kwiksk13.pdf

The meeting was among other things to strategize on the next steps for the campaign. In 2009 the Stock-out Campaign received a lot of attention. Journalists were interested by the novel news angle that the use of innovative technology provided.

The campaign that took place in five African countries namely Kenya, Uganda, Zambia, Zimbabwe and Malawi made several milestones. Most importantly, the campaign empowered patients and consumers by the knowledge that they were entitled to access essential medicines. Civil society activists also realized that they could monitor drug availability and challenge the status quo through advocacy.

Through lobbying and advocacy the campaign held governments and policy makers to account for denying the reality about stock outs of essential medicines in public health facilities and failing to take action. Drug supply agencies were shamed into becoming more transparent, efficient and accountable. Politicians and policy makers started to respond publicly to this pressure.

In 2010 the Campaign will use this public attention and heightened profile to continue pushing for concrete government response to end the stock-outs.

Some in country focuses in 2009
Kenya
In Kenya, activists decided to target, amongst others, the central medicines supply agency for their advocacy campaign. The Kenya Medical Supplies Agency (KEMSA), under the Ministry of Medical Services, is mandated to procure and supply quality medical supplies to public health facilities. It is also required to replenish stocks of medical supplies in all public health facilities in the country. Inefficiencies and lack of transparency at the level of the central medicine supply agency were identified as a major bottleneck in Kenya. KEMSA became the target of major activist communication calling for increased transparency in the medical supply chain/system and adequate oversight of KEMSA.
The campaign was first met with flat out denial by the Ministry of Medical Services, which issued a press statement denying the very existences of stock-outs (“There are no stock-outs of essential drugs experienced in the country as reported by the media.”). After 5 months of campaigning and the Pill Check Week, the Minister of Medical Services Prof Anyang Nyongo, admitted on a Kiswahili radio station that there were stock-outs in public health facilities in Kenya. He also confirmed to lawmakers that extra funds would be used to purchase essential medicine.

Malawi
In Malawi, the team decided to focus on improving procurement efficiency and strengthening the management of the medicine supply chain in order to improve availability in all districts with low access. The elections in Malawi provided a great opportunity to get the issue of access to essential medicines onto the election agenda at local levels and to pressure politicians to provide answers on how they will stop stock outs in their districts if elected.

Campaign partners targeted aspiring members of Parliament and presidential candidates. They issued a “Medicines for All pledge” and asked communities to demand commitment and accountability from MPs on accessing essential medicines. Community members called on all aspiring Members of Parliament to sign the “Medicines for All Pledge” to stop the stock-outs. The pledge committed politicians to:
• Pledge to stop the stock-outs and support drugs policies that ensure that all Malawians have access to essential medicines regardless of where they live.
• Promise to maintain and improve poor people’s access to basic essential medicines.
• Pledge to support actions designed to strengthen distribution of these drugs.
• Promote transparency and accountability so that there is public disclosure on medicines supplies.

This movement was widely supported by print, television and radio coverage. The team held a panel discussion with key aspiring MPs from the three key political parties on the “Medicines for All Campaign”. The debate was recorded by Zodiac Radio and aired for two hours. The Stock-out Campaign also prompted the Minister of Health to react and position himself publicly. At the Health Sector SWAp, in his opening remarks, the minister felt obliged to account for the performance of the Ministry in providing essential medicines and called out to Martha, one of the leaders in the Stop the Stock-outs Campaign: “Martha Kwataine, Are you here?” he said “are you listening?”; a clear sign that the message in the Campaign on drug stock-outs had reached the ears of the powerful.

Uganda
The Ugandan team made an interesting use of World TB Day to put the issue of drug stock-outs on the agenda. Their statement read: “As people around the globe mark the World Tuberculosis (TB) Day, we the partners of the Stop Stock-Outs Campaign in Uganda are extremely concerned that even at this very moment there is a stock-out of anti-TB drugs at Mulago Hospital, Uganda’s national referral hospital.”

Their communication went on to denounce the shortages of essential medicines that prevail at national referral hospitals and lower level health facilities, which had continued for more than seven months, and how the Ugandan Government was failing in its duty to provide quality essential medicines under the International Covenant on Economic, Social and Cultural Rights. The partners of the Stop Stock-outs Campaign in Uganda asked the Government to take action to make available quality TB medications at Mulago Hospital and all other public health facilities in the country where there were stock-outs; revise the medicines procurement, supply and distribution mechanism; and ensure the timely availability of TB and other essential medicines to those who need them.

The Uganda Stop Stock-outs team’s statements about TB drugs stock outs at Mulago hospital caught significant press attention, including in the regional weekly paper “The East African” and in ASNS (Africa Science News Service). As a result of the wide media coverage of the stock-out issues (and especially the TB medications), the Ministry of Health came out openly and acknowledged the drug shortages taking place in the country on prime-time TV news.

Zimbabwe
The Zimbabwean teams were only able to start their campaign work in late summer 2009. Partners have decided amongst other issues, to campaign on documenting and responding to corruption in the drug supply system as well as pushing for resource mobilization. To that end, participants in the campaign decided to engage the Parliamentary Portfolio Committee on Health (PPCH) to ensure the prioritization of health evidenced by increased allocation of resources.

The Pill Check Week
To keep and feed the momentum created by the launch in February 2009, it was then decided to identify a common week during (22 – 26 June) which teams of people would go out to pharmacies and document which of a list of 10 Essential medicines were out of stock. Through a simple text message sent via mobile phones to a central computer, an interactive map was created on the stoptockouts.org campaign website, which visually showed the extent of stock-out as encountered by people in the field. This creative use of the mobile phone technology attracted significant attention from national and regional journalists, and soon led to an opening up of the debate on stock-outs. Prior to this mainstream media had largely ignored the problem.

How the SMS pill check week was done:
Activists in Kenya, Uganda, Malawi and Zambia started surveying clinics in their respective countries, checking stock levels of essential medicines. These included first-line anti-malarials, zinc tablets, penicillin, and first-line anti-retrovirals (ARVs) for the treatment of HIV/AIDS. Each of these medicines is essential in varying degrees to fighting disease and illness, and is widely used in the four countries. After visiting clinics and pharmacies, activists used their mobile phones to report their results by using structured, coded text messages (SMS): “x,y,z” – where the x represented their country code (Kenya, Malawi, Uganda or Zambia), y their district or city, and z the medicine which they found to be out of stock. The messages were received by “FrontlineSMS”, a free open source software. When a stock-out SMS report was received, “FrontlineSMS” was configured to run an automatic script which sent the stock-out report to the Campaign website where it was visually displayed on an interactive map. This map showed specific reports by location, building up “hot spots” of activity – the bigger the hotspot, the greater number of stock-outs and the greater the problem in that area.

African Union level
With the support of PHP’s Access to Essential Medicines Initiative, HAI-Africa and Oxfam Pan African office and the Treatment Access Movement organized a workshop at the African Union (AU) level to brief Ambassadors, AU staff and other stakeholders and examine strategies for reducing stock-outs of medicines in public health facilities, and improving access to essential medicines in Africa. The meeting kicked off with a roundtable discussion with key continental and sub-regional policy makers relevant to ensuring access to medicines, and drawn from the African Union, the Southern Africa Development Committee (SADC), the East African Community (EAC) and the Economic Community of West African States (ECOWAS).
Of specific interest was the angle offered by the set of commitments made by the Member States of the African Union since 2001. The commitments that most directly impact the ability of African citizens to access essential medicines are the pledges made to:
• Allocate 15% of national budgets to health
• Strengthen health systems to ensure that essential medicines are in stock
• Enact and utilize appropriate legislation, trade regulations and TRIPS flexibilities to ensure that essential medicines are available and affordable
• Support the Pharmaceutical Manufacturing Plan for Africa, which is aimed at realizing the economic production at volume of quality generic medicines.

The lack of progresses against these set of continental commitments and declarations related to access to medicines was highlighted. Participants urged African governments to eliminate stock-outs from all public health institutions by providing a dedicated national budget line for essential medicines, ensuring complete autonomy of central medical stores, and providing effective representation of civil society on the boards of national and regional procurement agencies.

To see more materials about the meeting click on the links below:
http://accessmedicines.wordpress.com/
http://health.accel-it.lt/en/seminars/

Els Torreele of OSI making a presentation at the Meeting